RX Drugs Information:

DRUG DESCRIPTION

LIDEX (fluocinonide) Cream 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6?,11?,16?)-. It has the following chemical structure:

What are the possible side effects of fluocinonide topical (Fluocinonide-E, Lidex, Lidex-E, Vanos)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

blurred vision, or seeing halos around lights;

mood changes;

sleep problems (insomnia);

weight gain,...

Read All Potential Side Effects and See Pictures of Lidex »

What are the precautions when taking fluocinonide (Lidex)?

Before using fluocinonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you...

Read All Potential Precautions of Lidex »

Lidex Consumer (continued)

SIDE EFFECTS: Burning, itching, irritation, or dryness may occur when this medication is first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Skin infections can become worse when this medication is used. Notify your doctor if redness, swelling, or irritation does not improve.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluocinonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

Brand Names: Fluocinonide-E, Lidex, Lidex-E, Vanos

What is the most important information I should know about fluocinonide topical (Lidex)?

What should I discuss with my healthcare provider before using fluocinonide topical (Lidex)?

How should I use fluocinonide topical (Lidex)?

What happens if I miss a dose (Lidex)?

What happens if I overdose (Lidex)?

What should I avoid while using fluocinonide topical (Lidex)?

What other drugs will affect fluocinonide topical (Lidex)?

Where can I get more information?

What is fluocinonide topical (Lidex)?

Fluocinonide is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinonide topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Fluocinonide topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluocinonide topical (Lidex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

blurred vision, or seeing halos around lights;

mood changes;

sleep problems (insomnia);

weight gain, puffiness in your face; or

muscle weakness, feeling tired.

Less serious side effects may include:

mild skin itching, burning, peeling, or dryness;

headache;

stuffy nose, sore throat;

thinning or softening of your skin;

skin rash or irritation around your mouth;

swollen hair follicles;

changes in color of treated skin;

blisters, pimples, or crusting of treated skin; or

stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluocinonide topical (Lidex)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.